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The Motley Fool April 26, 2011 Brian Orelli |
There Is Only Downside in Consensus Hepatitis C advisory panels will almost certainly recommend approval. Almost. |
The Motley Fool January 21, 2011 Brian Orelli |
Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. |
The Motley Fool September 7, 2007 Brian Orelli |
Merck Says No to This Protein An FDA advisory panel recommends unanimous approval of a new HIV drug from Merck. The new class of HIV medications fight the virus by blocking one key protein from entering cells. |
The Motley Fool April 25, 2011 Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
The Motley Fool March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
The Motley Fool April 13, 2011 Brian Orelli |
Drug Duo Escapes Advisory Panel Unharmed Pfizer and Novartis are on their way to expanding their cancer drug indications. |
The Motley Fool November 29, 2007 Brian Lawler |
Another Chapter in Glaxo's Relenza Saga An FDA advisory panel suggested that the Relenza label should be strengthened to include the possibility of abnormal behavior and hallucinations in those who take it. |
The Motley Fool August 4, 2010 Brian Orelli |
No Nail Yet, but Vertex Creeps Up to Merck's Coffin Merck's hepatitis C data doesn't look as good as Vertex's. |
The Motley Fool June 26, 2009 Brian Orelli |
Looking for a Sliver of the Me-Too Pie Another diabetes drug is close to hitting the market. |
The Motley Fool February 4, 2009 Brian Orelli |
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval. |
The Motley Fool March 8, 2010 Brian Orelli |
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. |
The Motley Fool March 31, 2011 Brian Orelli |
Hepatitis C Drugs Heat Up The current hepatitis C drugs stink. Who's ahead in the race to find new ones? |
The Motley Fool December 11, 2009 Brian Orelli |
Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no. |
The Motley Fool May 17, 2011 Luke Timmerman |
Merck, Genentech Team Up on Hepatitis C Drug Merck pulling lots of strings to grab market share against Vertex. |
The Motley Fool January 24, 2008 Brian Lawler |
Vertex Under the Gun Vertex announces development plans for its lead drug. Investors, take note. |
The Motley Fool June 16, 2011 Brian Orelli |
Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA. |
The Motley Fool September 9, 2010 Brian Orelli |
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. |
The Motley Fool April 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
The Motley Fool May 18, 2011 Brian Orelli |
If You Can't Beat 'Em, Use 'Em to Beat Your New Rival Merck is supposed to be a bitter rival to Roche in the hepatitis C space. Instead, it's extending the hand of friendship. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool June 16, 2011 Brian Orelli |
No Poke in the Eye Here What's the biggest sign that the Food and Drug Administration is all set to approve Regeneron Pharmaceuticals' Eylea? The briefing documents for the advisory committee contained a proposed version of the label. |
The Motley Fool October 16, 2007 Brian Orelli |
Not a Blockbuster -- Yet Merck gains marketing approval for its newest HIV drug. Investors, take note. |
The Motley Fool July 29, 2011 Brian Orelli |
Vroom! There Goes Vertex Vertex Pharmaceuticals' Incivek launch is off to a good start. |
The Motley Fool November 19, 2010 Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
The Motley Fool September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
The Motley Fool March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
The Motley Fool March 28, 2011 Brian Orelli |
Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news. |
The Motley Fool November 30, 2007 Brian Lawler |
FDA Throws Adolor a Bone Pharmaceutical company Adolor gets an advisory panel hearing on its lead drug. Investors, take note. |
The Motley Fool September 7, 2010 Luke Timmerman |
Vertex Nails Third Big Trial With Hepatitis C Drug And in the toughest patients to treat, too. |
The Motley Fool June 11, 2010 Brian Orelli |
25 to 0! Now That's a Ringing Endorsement Novartis flies through its advisory panel meeting nearly unscathed. |
The Motley Fool July 29, 2010 Brian Orelli |
This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either. |
The Motley Fool September 8, 2010 Brian Orelli |
You Must Realize This Drug Works by Now Vertex concludes its phase 3 trials with another win. |
The Motley Fool December 14, 2007 Brian Orelli |
Panel Kills Merck's Hope of OTC Status An FDA advisory panel isn't convinced that Merck's cholesterol-lowering drug MEVACOR deserves OTC status. |
The Motley Fool March 28, 2008 Brian Orelli |
The Yin and Yang of Schering's Label Changes Schering gets a pair of label changes that have opposite effects for its hepatitis C drug. |
The Motley Fool August 11, 2010 Brian Orelli |
Dang! This Drug Is Shining Brighter Vertex illuminates telaprevir's additional benefit in treating hepatitis C patients. |
The Motley Fool March 20, 2008 Brian Lawler |
Gilead Not Slowing Gilead Sciences gets a new approval for a drug. |
The Motley Fool April 29, 2008 Brian Orelli |
Merck's Recovery Flushed Down Merck's best hope at recovery fails approval by the FDA. |
The Motley Fool October 31, 2011 Brian Orelli |
When Getting Beat Down Is No Big Deal Merck is getting smacked down by Vertex Pharmaceuticals in the hepatitis C market, but it has the bulk to take a beating. |
The Motley Fool January 28, 2011 Brian Orelli |
Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result. |
The Motley Fool August 21, 2008 Brian Orelli |
Johnson & Johnson Gets Rejected The FDA rejects Johnson & Johnson's bid to expand the label of its antibiotic. |
The Motley Fool April 2, 2009 Brian Orelli |
A Diabetic Compromise Bristol-Myers and AstraZeneca will have to test their drug after it goes on the market. |
The Motley Fool August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals |
The Motley Fool September 10, 2008 Brian Lawler |
A Pfizer Drug With a Cloudy Future The company offers another drug with mixed odds to the FDA. |
The Motley Fool July 13, 2010 Brian Orelli |
A Triple Delight: 3 Stocks All Up More Than 10% What's good for the obese goose is good for the gander when it comes to new drug treatments for losing weight. |
The Motley Fool March 17, 2008 Brian Lawler |
The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared. |
The Motley Fool June 14, 2010 Brian Orelli |
No Approval? No Problem! Investors shrug off Human Genome's news about its hepatitis C drug Zalbin. |
The Motley Fool August 30, 2007 Brian Lawler |
Human Genome Steps Forward Human Genome Sciences investors got good news as the drugmaker took a quicker-than-expected step in its journey to get its lead drug, hepatitis C treatment Albuferon, on the path to FDA approval. |
The Motley Fool December 6, 2010 Brian Orelli |
3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise. |
The Motley Fool July 25, 2007 Brian Lawler |
GPC Must Wait An advisory panel recommends against approving GPC's lead drug right now. Investors, take note. |